Kornimate/medical-research-clean huggingface dataset:
second follow-up study of copd patients and healthy controls for evaluation of predictive non-coding rna biomarkers

Conditions: Chronic Obstructive Pulmonary Disease

Summary: between 2012 and 2014, a cohort of 90 copd subjects of disease severity grades gold i-iv as well as 60 healthy control subjects (30 smokers and 30 non-smokers) have been examined regarding different clinical and blood/ sputum derived biomarkers at the investigators' research center. of this cohort, 116 subjects were re-invited for the first follow-up study ribolution ii (ntc02522026) after 3 years (+/- 6 months) and data on the clinical course and treatment changes was obtained. this second follow-up study will re-examine all available subjects regarding disease course and treatment changes after 3 years (+/-6 months) for the investigation of ncrna/ transcriptome biomarkers for their potential to indicate disease progression. in addition, biobanking of respective biosamples for potential future copd biomarker research will be conducted.


Eligibility criteria:
inclusion criteria: 1. participation in the study "11-03 ribolution". 2. able and willing to give written informed consent. 3. females will be considered for inclusion if they are: not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing. exclusion criteria: 1. any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, lung function or ecg at screening visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study. 2. past or present disease developed after the participation in "11-03 ribolution" or "15-01 ribolution ii", which might interfere with study procedures. 3. participation in another clinical trial 30 days prior to enrollment. 4. current drug or alcohol abuse. 5. risk of non-compliance with study procedures. 6. suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study. 7. history of an acute infection four weeks prior to the study procedures, including - but not limited to - moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalization). all courses of oral corticosteroids and antibiotics must be completed at least four weeks prior to all study procedures (with the exception of the informed consent). in case of significant acute infections or moderate or severe exacerbation, the study participation can be split in two separate visits (1. informed consent visit, 2. study procedures visit, when subject is fully resolved, at least four weeks after the end of infection/ exacerbation). 8. if performed according to sop fhi-1-18, positive sars-cov-2 rapid antigen test on day 1. subjects may be re-screened when confirmatory nucleic acid amplification test was negative or when officially ordered quarantine has ended. 9. being a vulnerable subject (dependent, in detention or without mental capacity).
safety and antiviral activity of entecavir in participants with chronic hepatitis b following monotherapy in other entecavir trials

Conditions: Hepatitis B Virus; HBV

Summary: the purpose of this study is to provide entecavir to participants who have completed another entecavir trial without achieving virologic response or who relapsed during postdosing follow-up.


Eligibility criteria:
key inclusion criteria: * age of 16 years and older * receipt of entecavir or lamivudine in a previous entecavir study. participants who were, based on their response to entecavir: * virologic nonresponders at week 48 * partial virologic responders who became nonresponders during the second year of treatment * partial virologic responders at week 96 * complete responders who relapsed during postdosing follow-up * decompensated liver disease in ai463-048 that met 1 or more of the following criteria: * nonresponse to adefovir after at least 24 weeks of treatment * partial response to adefovir after 96 weeks of treatment * complete response to adefovir after relapsing during postdosing follow-up * demonstrated intolerance to adefovir * except for those participants enrolled from ai463-048, compensated liver disease. key exclusion criteria: * hiv coinfection * receiving nephrotoxic or hepatotoxic agents * ongoing opportunistic infections * hemoglobin level \<11.0 g/dl except for those enrolled from ai463-048 * platelet count \<70,000 mm\^3 except for those enrolled from ai463-048 * absolute granulocyte count \<1,500 cells/mm\^3 * recent history of pancreatitis (within 24 weeks prior to first dose of therapy) * current evidence of ascites requiring paracentesis, hepatic encephalopathy, or variceal bleeding, except for those enrolled from ai463-048 * known history of allergy to nucleoside analogues.
peripheral and coronary endothelial dysfunction in type 2diabetic patients- role of metformin

Conditions: Coronary and Peripheral Endothelial Dysfunction

Summary: peripheral and coronary endothelial dysfunction in type 2 diabetic patients may be influenced by therapeutics. using radial flow monitoring and myocardial perfusion magnetic resonance imaging, we designed a controlled randomized double blind study to test the hypothesis that endothelial dysfunction will be reversed following 3 months of metformin administration vs gliclazide. 30 patients will be included.


Eligibility criteria:
inclusion criteria: 18-70 years old, type 2 diabetes, non significant coronary atherosclerosis on inclusion coronary angiogram (ie no coronary stenosis \> 70%), hba1c\<9% exclusion criteria: significant coronary stenosis (\>70%), lack of informed consent, unstable hypertension, renal failure, contra-indication to metformin or gliclazide, pregnancy, atrial fibrillation, contraindication to mri, or to adenosine, brachial artery calcifications

Keywords: diabetes, coronary endothelial dysfunction, metformin, glyclazide, mri.
impact of the elevation training mask in crossfit® post-sars-cov-2 infection.

Conditions: COVID19- Infection with SARS-CoV-2 Virus; SARS-CoV-2 Positive Patients; COVID-19 Pulmonary Complications; SARS-CoV-2 Infection (Symptomatic)

Summary: introduction: the elevation training mask (etm) could restore respiratory or hematological organic damages from the acute or post-infection phase of severe acute respiratory syndrome coronavirus 2 (sarscov2) because it would allow the application of hypoxia and respiratory muscle training during exercise. the aim of this study was to comparatively evaluate the respiratory and hematological parameters and performance of athletes who resume crossfit® training using the etm with respect to a control group (cg). material and methods: a single-blind randomized clinical trial, following the consort ("consolidated standards of reporting trials") recommendations, 20 trained male athletes were randomly assigned to an experimental group (eg) using the etm and to a cg using the simulated etm, they completed 12 weeks of crossfit® training after 1 month of the cessation of sars-cov-2 symptoms. pre- and post-training tests included spirometric, hematological, and sports performance assessment.


Eligibility criteria:
inclusion criteria: * male aged 18 to 50 years. * autonomy in training activities of crossfit® programs, at least 1 month after the cessation of symptoms of sars-cov-2 infection -2 infection. * no hospitalization for covid-19. * autonomy in training activities of crossfit® programs, at least 1 month after the cessation of symptoms of sars-cov-2 infection, to avoid residual effects of the disease and increase the safety of the athlete. * ≥20 months of experience training crossfit®. * ≥2 participations in crossfit® competitions in the last season. * having completed fran wods ≤ 250 seconds before suffering from covid-19. - passing a complete pre-study medical examination to rule out pre-existing diseases or injuries, insisting particularly on the cardio-pulmonary examination.-- no consumption of illegal drugs according to the world anti-doping agency (wada) (stimulants, blood derivatives, anabolic) or take drugs (e.g. tramadol) or other ergogenic products. * be informed about all possible risks or discomforts and benefits associated with the study and sign the informed consent form;. * health sports insurance coverage. exclusion criteria: * included any renal dysfunction, recent febrile illness, lower limb trauma or any history of muscle injury. * sars-cov-2 reinfection during the study. * recent exposure to an altitude stimulus or hypoxia, except for the altitude of their usual residence (1063 m in soria and 798 m in salamanca). * participants were also prevented to perform any intense physical activity outside the designed training protocol throughout the study and encouraged to follow the dietary instructions provided.

Keywords: elevation training mask sars-cov-2 crossfit® spirometric parameters hematological biomarkers wod
senescent immunity in elders and vaccine responses (silver)

Conditions: Flu Vaccine

Summary: to study the effects of age on the immune system's response to flu vaccine and to study the connection between the immune system and physical and cognitive changes associated with aging.


Eligibility criteria:
inclusion criteria: * age 65 years and over * independent living (including assisted living) exclusion criteria: * unable to understand the consent or the study. * allergic to any vaccine components, excluding eggs. * history of guillain-barre. * residing in a long -term care facility such as a nursing home.

Keywords: adult 65 and older
neoadjuvant chemotherapy for locally advanced thymic cancer

Conditions: Locally Advanced Stage III or IV Thymic Cancer

Summary: we try to evaluate whether neoadjuvant docetaxel plus cisplatin can increase the complete resection rate in advanced thymic carcinoma.


Eligibility criteria:
inclusion criteria: * histologically confirmed thymic carcinoma * surgically inoperable masaoka stage iii or iv * ecog 0-2 * at least one measurable disease exclusion criteria: * previous myocardiac infarct history within 1 year before the enrollment.

Keywords: neoadjuvant chemotherapy thymic cancer
the critical care response to the covid-19 pandemic in madrid

Conditions: COVID-19; ARDS, Human

Summary: description of the adaptation of icus in the region of madrid to que surge in demand of critical care due to covid-19

background the worldwide sars-cov-2 pandemic has put healthcare systems under the extreme pressure, with intensive care units being faced with a previously unseen number of patients with severe respiratory failure requiring admission for endotracheal intubation and mechanical ventilation. methods the study describes how the critical care resources adapted to the sudden surge of severe covid-19 in the province of madrid, which developed at the beginning of march 2020. the response consisted of a swift increase in icu capacity and the relocation of patients. icu beds were mounted outside the usual intensive care areas. transfer of critically ill intubated patients with covid-19 was managed in an instant messenger service group composed of representatives of 53 intensive care units and performed by the madrid emergency medical systems (ems). the investigators will compare transferred with non-transferred patients matched for risk factors for cardiovascular and respiratory complications.

Eligibility criteria:
inclusion criteria: * admitted to icu in madrid with covid-19 exclusion criteria: * admitted to icu without covid-19

Keywords: covid-19 ards relocation icu capacity
monopolar current cutting knife vs bipolar rfa knife

Conditions: Gastrointestinal Neoplasms

Summary: this is a prospective, randomized trial that aims to study the efficacy and clinical outcomes of a novel bipolar knife vs. monopolar knives on patients who undergo endoscopic submucosal dissection (esd) procedure at baylor st. luke's medical center.

endoscopic submucosal dissection (esd) is a novel technique for the removal of advanced colonic polyps with high-risk features. esd is minimally invasive and allows the removal of colonic adenomatous polyp without resorting to surgery. the process of esd includes marking the lesions selected for removal, followed by submucosal injection of a lifting agent, then circumferential incisions using a specialized knife followed by submucosal dissection of the entire lesion. traditionally, knifes utilizing monopolar current such as dual knife or hybrid knife were the preferred tools for endoscopic submucosal dissection. these knifes allows accurate dissection and excellent hemostasis. however, due to monopolar current generated heat, post coagulation syndrome can be seen in up to 8 to 40 % of patients. post coagulation syndrome present with abdominal pain, fever and leukocytosis and requires supportive treatment with iv fluid and antibiotics. recently, a novel bipolar radiofrequency ablation (rfa) knife were approved by fda for the performance of esd. the knife utilizes bipolar rfa current for submucosal dissection which can potentially expedite submucosal dissection and decrease the rates of post polypectomy syndrome. our tertiary referral center baylor st luke's medical center is center of excellence for esd procedure and we have previously reported our esd experience using specialized stability and traction device and monopolar current knife in 111 patients. the goal of our protocol is to compare the performance of monopolar current cutting knife and bipolar rfa knife in colonic endoscopic submucosal dissection.

Eligibility criteria:
inclusion criteria: 1. patient is ≥ 18 years old 2. patient is capable of providing informed consent 3. patient is referred for esd procedure of gastrointestinal neoplastic lesions exclusion criteria: 1. patient is \< 18 years old 2. patient refused and/or unable to provide consent 3. patient is a pregnant woman 4. patients with lesions removed with other techniques besides esd or a modified esd technique (i.e., emr or tem) as defined in the japan gastroenterological endoscopy society (jges) guidelines for endoscopic resection of lesions.

Keywords: endoscopic submucosal dissection
study on the possible effects of diet supplementation with essential fatty acids in chocolate craving volunteers

Conditions: Addictive Behavior; Abstinence Syndrome

Summary: the purpose of this study is to determine whether essential polyunsaturated acids (omega 3) are capable of reducing chocolate craving symptoms in healthy patients. our hypothesis is that the omega 3 fatty acids have properties which stabilize and normalize neuronal functioning in many conditions, including chocolate craving.

polyunsaturated fatty acids (of the omega 3 subtype) are fundamental in human diet, as they are components of cellular membranes, guaranteeing their fluidity and their functions of separating intracellular and extracellular means and transporting several substances to and from cellular microenvironment. modern theories profess that lack of omega 3 fatty acids in western diets may be the cause of several deletery changes in neuronal physiology, which may cause or make worse several pathological conditions, such as depression, mood instability, and drug craving. the role of serotonin as the main lacking component in the conditions is well documented, and it is thought that omega 3 is important in the synthesis, transportation, and ultimately the activity of this neurotransmitter. out theory states that supplementation with these acids can restore normal neuron balance, improving the condition of chocolate craving patients.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of chocolate compulsion or craving, ecap score \> 12. exclusion criteria: * psychiatric disease of any sort (by the dsm iv criteria, use of psychoactive drugs of any sort, bmi \> 25 (kg/m2).

Keywords: chocolate craving addiction compulsion
acetaminophen randomized controlled trial

Conditions: Post Operative Pain

Summary: patients that are to undergo isolated meniscectomy will be randomized to 2 cohorts: one will take the fda recommended dose of acetominophen (1000mg) 24hrs before surgery, one will be given a similarly looking placebo pill. a multitude of post-op variables will be included, mainly pain scores and morphine equivalent doses at different time points.


Eligibility criteria:
inclusion criteria: * must be at least 18 years of age * asa class i-ii * patients scheduled for meniscectomy exclusion criteria: * contraindication to acetaminophen (hypersensitivity, extensive alcohol history, liver disease, actively breastfeeding) * legally incompetent or mentally impaired (e.g., minors, alzheimer's subjects, dementia, etc.) * younger than 18 years of age or older than 65 * any patient considered a vulnerable subject * patients on pain medication prior to surgery

Keywords: acetaminophen surgery meniscectomy
a pilot smart design for pathological gamblers

Conditions: Pathological Gambling

Summary: pathological gambling is serious problem, with significant psychological, financial, and public health consequences. nevertheless, controlled trials examining the efficacy of therapeutic interventions for pathological gamblers are sparse, and many pathological gamblers recover on their own, or with only minimal interventions. in this initial study of a smart design for pathological gamblers, we will offer a brief intervention to all (n = 100), and subsequently randomize individuals based upon their initial treatment response to varying intensities of additional care from none to 8 sessions of individual cognitive behavioral therapy (cbt) plus 14 weeks of aftercare. gambling outcomes will be assessed pre-treatment and at about weeks 10, 24, 36 and 52.


Eligibility criteria:
inclusion criteria: * age \> 18 years old, dsm-iv criteria for pathological gambling * \>2 gambling episodes in past 60 days * spent \>$100 wagering in the past 60 days * willingness to accept random assignment after the brief intervention. exclusion criteria: * reading level below 5th grade * uncontrolled psychiatric conditions (e.g., active suicidal intention, psychosis, bipolar disorder)

Keywords: pathological gambling cognitive-behavioral therapy motivational enhancement therapy
ci-994 in treating patients with advanced myeloma

Conditions: Multiple Myeloma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of ci-994 in treating patients who have advanced myeloma.

objectives: i. determine the antitumor activity of ci-994 in patients with advanced myeloma. ii. determine the response rate, response duration, and overall survival of this patient population with this treatment regimen. iii. determine the safety of this treatment in these patients. outline: this is a multicenter study. patients receive ci-994 orally daily. treatment continues in the absence of disease progression or unacceptable toxicity. patients are followed for 30 days and then every 2 months. projected accrual: a total of 8-63 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically confirmed stage iia or iiia myeloma with a measurable m- component in the serum or urine progressing disease after conventional chemotherapy patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: greater than 8 weeks hematopoietic: absolute neutrophil count at least 1,500/mm3 platelet count at least 75,000/mm3 (transfusion independent) hepatic: bilirubin no greater than 2 times upper limit of normal (uln) ast/alt no greater than 2 times uln renal: creatinine no greater than 1.5 times uln calcium no greater than 12 mg/dl other: not pregnant or nursing fertile patients must use effective contraception no life threatening illness unrelated to the tumor no concurrent serious infection no prior malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix must be capable of swallowing intact medication capsules no medical or psychiatric condition that would prevent written informed consent prior concurrent therapy: biologic therapy: at least 14 days since prior immunologic agents no concurrent immunologic agents chemotherapy: see disease characteristics at least 3 weeks since prior chemotherapy no concurrent chemotherapy endocrine therapy: at least 2 weeks since prior high dose corticosteroids no concurrent anticancer hormonal therapy no concurrent corticosteroids radiotherapy: at least 3 weeks since prior radiotherapy and recovered no concurrent radiotherapy surgery: not specified

Keywords: refractory multiple myeloma stage ii multiple myeloma stage iii multiple myeloma plasma cell neoplasm
how to prevent complications during dialysis

Conditions: Dialysis Related Complication

Summary: we aimed to determine the effect of accurate assessment of dry weight based on measuring blood sodium level before dialysis to evaluate the effect of adjustment of ultrafiltration rate on hemodialysis complications and take a step forward to improve patient care and the quality of hemodialysis.

dialysis has become an integral part of daily routine for kidney failure patients. so, if we can reduce complications during sessions, we will reduce the burden of life as a whole ¬. haemodialysis problems are frequent (1). the definitions of dry weight have changed over time but can be defined as the lowest post-dialysis weight tolerated without significant signs of hypovolaemia.(2) it should be mentioned that the incidence of complications during hemodialysate depends on the balance between the rate of ultrafiltration and changes in plasma volume. the amount of ultrafiltration is typically determined by calculating the patient's dry weight.(3) common problems during haemodialysis, in order of frequency, are: hypotension of around 23%, muscle cramps of roughly 10 to 20%, and nausea and vomiting of 10%. (4, 5). about 60 to 90% of dialysis patients suffer fatigue, which is one of the most prevalent complaints in people receiving hemodialysis.(6) aggressive ultrafiltration and targeting an inappropriately low dry weight can lead to intradialytic hypotension (idh), nausea, central nervous system dysfunction, cramping, and risks compromising vascular access and worsening residual renal function.(7) determining the patients' accurate dry weight is essential to minimizing these issues. when dry weight is accurately determined, quick variations in blood volume are avoided, which lowers the risk of problems during haemodialysis(8). the measurement of arterial natriuretic peptide (half-life of approximately 2 to 4 minutes), cyclic guanidine monophosphate, the diameter of the inferior vena cava (by echocardiography), bioimpedance (based on resistance measurement), and blood volume (by tracking changes in serum protein and hemoglobin) are used to determine dry weight.(9, 10) these techniques frequently need specialized equipment and are expensive. however, one practical way to measure dry weight prior to dialysis is to measure the amount of sodium, the most prevalent cation in extracellular fluid .(11)

Eligibility criteria:
inclusion criteria: - 6- not dependent to mechanical ventilation 1. at least one year history of hemodialysis 2. adults aged 18 to 65 years old 3. ability to communicate verbally 4. with no history of diabetes mellitus, urinary incontinence syndrome, heart and liver failure, and adrenal hypertrophy 5 -no use of antihypertensive and antispasmodic drugs four hours before dialysis exclusion criteria: 1- impaired consciousness 2- participant's withdrawal from the study 5-death 3- severe blood supply problem in the fistula or vascular access 4-migration or travel during the study -